BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16056974 · Received December 27, 2022

    Report

    Report Number
    3002682307-2022-00352
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 8, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309210 AND LOT NUMBER 2031729. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, TWO SYRINGES WERE OBSERVED WITHOUT THE TIP COMPONENTS. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN INLINE DETECTION SYSTEM WHICH INSPECTS ALL SYRINGES AND AUTOMATICALLY REJECTS ANY DEFECTS IDENTIFIED. THIS INCIDENT MOST LIKELY RESULTED FROM A BLOCKAGE DURING THE BARREL FEEDING PROCESS. AFTER THE BLOCKAGE, THE SYRINGE TIP WAS DAMAGED BUT WENT UNDETECTED BY THE ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE THE TIP OF THE SYRINGE HAD BROKEN OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NEED TO LET YOU KNOW OF ANOTHER CASE ¿ THE CONE OF THE SYRINGE WAS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE THE TIP OF THE SYRINGE HAD BROKEN OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NEED TO LET YOU KNOW OF ANOTHER CASE ¿ THE CONE OF THE SYRINGE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139785 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2031729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown